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FDA Panel Considers Dynavax’s Heplisav Safety Database Insufficient

This article was originally published in The Pink Sheet Daily

Executive Summary

The sponsor’s proposal for a post-approval cohort safety study in 30,000 patients failed to alleviate the concerns of a majority of the vaccines advisory committee, which voted 8 to 5 with one abstention that available data do not support the safety of the hepatitis B vaccine.

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